What should a medical device sales representative do if an adverse event occurs during a procedure?
REPORTER | WHAT TO REPORT | REPORT FORM # | TO WHOM | WHEN |
---|---|---|---|---|
Manufacturers | 30 day reports of deaths, serious injuries and malfunctions | Form FDA 3500A | FDA | Within 30 calendar days of becoming aware of an event |
5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health | Form FDA 3500A | FDA | Within 5 work days of becoming aware of an event |
In order for medical device manufacturers to avoid liability for failure to comply with FDA reporting standards, the manufacturer should make sure that all sales representatives understand what an adverse event is and what the FDA reporting guidelines require, so that sales representatives know what events they must report and when those events must be reported.
Eric Zalud is chair of the Litigation Practice Group at Benesch, Friedlander, Coplan & Aronoff LLP. He focuses his practice on products liability matters including medical device defense.
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